Anavex Life Sciences Corp (AVXL)

[Steady_T]

Question #1. The trial population size was small. Avatar was with 33 subjects. Most likely the FDA would consider that too small to be pivotal trial. Anavex can ask the FDA about that. The worst they can say is run a bigger trial.

Question #2 The EMA will not see the Rett trial data. That is for a different indication so it is not relevant unless there were significant safety issues which there were none.

I also expected the pediatric Rett trial to be a success. It was not the clear success I expected. I gave a 99% probability. Now I give it 55% and that may require an additional trial.

Depending on what the FDA says when Anavex gets its meetings I think that Missling may give up on the voucher and go full speed ahead on AD.

There is a lot of the NDA that I hope Anavex has been preparing for Rett that can be directly used for the AD NDA. If Missling decides to go full speed on AD I expect to see an application for AD priority review to the FDA.

We shall see. My guess is how Missling chooses to proceed depends on the FDA guidance on Rett.